Paradigm Biopharmaceuticals Ltd (ASX:PAR)'s lead drug candidate has been fast-tracked by the US Food and Drug Administration (FDA) for a phase three osteoarthritis program.
The company’s Zilozul™ candidate, a form of existing molecule Pentosan Polysulphate Sodium (PPS) which Paradigm is repurposing for osteoarthritis, has secured the regulatory green light.
The FDA fast-track acknowledges osteoarthritis as a serious condition with unmet need, and indicates there’s potential for PPS to offer a treatment for the degenerative joint disease.
Thanks to the stamp, Paradigm can work more closely with the FDA as it develops the Zilosul™ program, paving the way for shorter review times.
Expediting development program
Speaking to the fast-track, Paradigm’s chief medical officer, Dr Donna Skettett, said: “This is welcome news from the US FDA as the company continues to gain momentum in site activation and participant screening across the 56 selected sites in the US.
“Given the need to improve therapeutic options for patients suffering from pain and loss of functionality associated with OA, we are excited to have this fast track designation granted for Zilosul™ and the regulatory support it provides in expediting the phase three development program to advance this promising treatment to patients sooner.
“Paradigm believes Zilosul™ would represent an important medical advance in the treatment of debilitating osteoarthritis pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”
Targeting an unmet medical need
Osteoarthritis is a chronic degenerative disease characterised by a progressive loss of cartilage, leading to pain, loss of joint function and disability.
It is the most prevalent form of joint disease, affecting up to 16% of the population in the developed world, with more than 72 million people in the US, EU, Canada and Australia suffering from osteoarthritis.
The prevalence of this joint disease is increasing in line with the aging population and increasing rates of obesity.
By 2030, the number of people suffering from osteoarthritis in the US alone is predicted to increase by 86% to 67 million.
If we assume a similar increase across the other markets listed above, even allowing for lower rates of obesity in non-US markets, it is estimated that more than 120 million people will be suffering from osteoarthritis by 2030.
The trial
Paradigm’s phase three program is designed to measure the change in pain and function after a subcutaneous injections of PPS compared with a placebo in participants with knee osteoarthritis pain.
This is a two-stage, adaptive, randomised, double-blind, placebo-controlled, multicentre study that will take place across three continents.
The primary endpoint in the trial will be the change from baseline at day 56 in the WOMAC® pain score.
Secondary outcomes will include the change from baseline at multiple time points out to day 168 in the WOMAC® pain and function, patient global impression of change and quality of life measures.
The global phase three clinical trial is currently screening and enrolling participants in both Australia and the US, with sites in Europe, UK, and Canada to be initiated.
About Paradigm
Paradigm is on a mission to take existing, approved drugs and apply them in a new, patented application.
The healthcare stock’s primary focus to date is its pipeline indications covering the use of pharmaceutical compound PPS, supported by full patent and IP protection.
Commercially speaking, Paradigm is immediately invested in repurposing PPS to treat osteoarthritis.
There’s a global unmet need surrounding this ailment and Paradigm has advanced its treatment candidate to phase three clinical trials that address all aspects of the disease — including inflammation, pain and regeneration.
A key feature of PPS’ activity is its anti-inflammatory and tissue regenerative properties, and Paradigm’s wider focus remains exploring PPS' use in treating the myriad conditions that begin with and are sustained by inflammation.
Other indications include the treatment of joint function, mobility and pain in patients with mucopolysaccharidoses (MPS), chronic heart failure (CHF), treating alphavirus induced arthralgia (in patients with Ross River Virus and Chikungunya); and allergic respiratory conditions, including allergic rhinitis (AR) and chronic obstructive pulmonary disease (COPD).